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Study of Vitamin C, Vitamin E and Their Combination to Treat Restless Legs Syndrome in Hemodialysis Patients (ShirazUMS)

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ClinicalTrials.gov Identifier: NCT01125033
Recruitment Status : Completed
First Posted : May 18, 2010
Last Update Posted : June 17, 2011
Sponsor:
Information provided by:
Shiraz University of Medical Sciences

Brief Summary:
The purpose of this study is to determine whether vitamin C, vitamin E and their combination are effective in the treatment of RLS in hemodialysis patients.

Condition or disease Intervention/treatment Phase
Restless Legs Syndrome Kidney Failure, Chronic Drug: Vitamin C & Vitamin E Drug: Vitamin C Drug: Vitamin E Drug: Vitamin C Placebo & Vitamin E Placebo Phase 2 Phase 3

Detailed Description:
RLS is a common problem in hemodialysis patients; 20 to 40% of hemodialysis patients suffer from RLS. Hemodialysis patients have a high oxidative stress status. Oxidative stress has been proposed to play an important role in the pathogenesis of RLS. Vitamin C and vitamin E are potent antioxidant agents that have already been shown to be effective in the treatment of periodic limb movement disorder (PLMD) in hemodialysis patients. PLMD is closely associated with RLS in hemodialysis patients. The aim of this study was to evaluate the efficacy of vitamin C, vitamin E and their combination in the treatment of RLS in hemodialysis patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Vitamin C, Vitamin E and Their Combination for Treatment of Restless Legs Syndrome in Hemodialysis Patients: a Randomized Double-blind, Placebo-controlled Trial
Study Start Date : March 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : February 2009


Arm Intervention/treatment
Experimental: Vitamin C & Vitamin E.
The patients in this arm received one tablet of vitamin C (200 mg) and one capsule of vitamin E (400 mg) daily for 8 weeks
Drug: Vitamin C & Vitamin E
The patients in this arm received one tablet of vitamin C (200 mg) and one capsule of vitamin E (400 mg) daily for 8 weeks

Experimental: Vitamin C & Placebo
The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks.
Drug: Vitamin C
The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks.

Experimental: Vitamin E & Placebo
The patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks.
Drug: Vitamin E
The patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks.

Placebo Comparator: Double Placebo
The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks.
Drug: Vitamin C Placebo & Vitamin E Placebo
The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks.




Primary Outcome Measures :
  1. Absolute Change in IRLS Sum Score [ Time Frame: 8 Weeks ]
    Absolute Change in IRLS Sum Score from Baseline to the End of Treatment Phase in Intention-to-treat Population


Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 8 Weeks ]
    Number of participants with adverse events throughout the treatment phase of the study would be assessed.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who fulfill Restless leg syndrome international criteria(IRLSSG)
  • Patients who are stable on HD without any internment illness or admission

Exclusion Criteria:

  • Patients who have renal stone
  • Patients who receive medications with RLS aggravating or alleviating properties

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125033


Locations
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Iran, Islamic Republic of
Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
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Principal Investigator: Hamideh Akbari, MD Shiraz University of Medical Sciences
Study Chair: Mohammad Mahdi Sagheb, MD Shiraz University of Medical Sciences
Principal Investigator: Sahar Sohrabi Nazari, MD Shiraz University of Medical Sciences
Principal Investigator: Mohammad Kazem Fallahzadeh, MD Shiraz University of Medical Sciences

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Responsible Party: Vice Chancellor for Research At Shiraz University of Medical Sciences, Shiraz Nephro-Urology Research Center
ClinicalTrials.gov Identifier: NCT01125033     History of Changes
Other Study ID Numbers: 86-3893
First Posted: May 18, 2010    Key Record Dates
Last Update Posted: June 17, 2011
Last Verified: June 2011

Keywords provided by Shiraz University of Medical Sciences:
Dialysis, Restless legs syndrome, Ascorbic acid, Vitamin E

Additional relevant MeSH terms:
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Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Syndrome
Renal Insufficiency
Psychomotor Agitation
Restless Legs Syndrome
Kidney Failure, Chronic
Disease
Pathologic Processes
Kidney Diseases
Urologic Diseases
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders
Renal Insufficiency, Chronic
Vitamins
Ascorbic Acid
Micronutrients
Nutrients
Growth Substances